Search Results
Found 1 results
510(k) Data Aggregation
(89 days)
OrthADAPT® PR is intended to be used for implantation to reinforce soft tissue, including but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, hernias. suture-line reinforcement and other reconstructive procedures.
The device is also intended for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.
OrthADAPT® PR is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons. Sutures, used to repair the tear, and sutures or bone anchors. used to attach the tissue to the bone, provide biomechanical strength for the tendon repair.
OrthADAPT® PR is comprised of collagen matrix reinforced by a woven polymer to provide permanent durability. The collagen matrix, which is derived from the same equine pericardial tissue used in the fabrication of its predicate device, the OrthADAPT® Bioimplant, has been decellularized and crosslinked and the entire device has been exposed to a liquid chemical sterilant. The product passes USP sterility testing and satisfies FDA requirements for LAL endotoxin limit for a medical device. The product must be rinsed prior to use following the procedures described in the Instructions for Use.
The provided text describes the OrthADAPT® PR Bioimplant, a surgical mesh device, and its substantial equivalence to predicate devices, rather than a study with acceptance criteria in the typical sense of diagnostic performance metrics (e.g., sensitivity, specificity). This documentation is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, not on proving device efficacy through a comparative performance study with predefined acceptance criteria for AI or diagnostic performance.
Therefore, many of the requested fields cannot be filled as they pertain to a different type of study (e.g., an AI/diagnostic performance study).
Here's the information available from the text, framed within the requested table and addressing the other points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for substantial equivalence) | Reported Device Performance (OrthADAPT® PR Bioimplant) |
|---|---|
| Intended Use: Equivalent to predicate devices. | Intended use for soft tissue reinforcement is comparable to predicate devices. Specifically: defects of abdominal/thoracic wall, muscle flap reinforcement, hernias, suture-line reinforcement, and other reconstructive procedures. Also for reinforcement of soft tissues repaired by sutures/suture anchors during tendon repair (rotator cuff, patellar, Achilles, biceps, quadriceps, etc.). |
| Technology: Similar to predicate devices. | Comprised of collagen matrix reinforced by woven polymer. Collagen matrix derived from equine pericardial tissue (same as predicate OrthADAPT® Bioimplant). Decellularized, crosslinked, exposed to liquid chemical sterilant. |
| Performance (Biocompatibility): Equivalent to predicate devices. | Biocompatibility test results indicate the device's biocompatibility profile is equivalent to the predicate devices. |
| Performance (Biomechanical): Equivalent to predicate devices and satisfies mechanical requirements for intended use. | Biomechanical test results indicate the device is equivalent to the predicate devices and satisfies mechanical performance requirements for its intended use. |
| Functionality & Tissue Response: Confirmed through in vivo study. | An animal implant study was performed to confirm the functionality and tissue response characteristics. |
| Sterility: Passes USP sterility testing. | The product passes USP sterility testing. |
| LAL Endotoxin Limit: Satisfies FDA requirements. | The product satisfies FDA requirements for LAL endotoxin limit for a medical device. |
The "study that proves the device meets the acceptance criteria" in this context refers to the collective body of biocompatibility testing, biomechanical bench testing, and an animal implant study, all performed to demonstrate substantial equivalence to predicate devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not explicitly stated. The document mentions "biocompatibility testing," "biomechanical bench testing," and "an animal implant study." The sample size for each of these tests is not quantified in the provided text.
- Data Provenance: Not explicitly stated. The document indicates the testing was conducted to support a submission to the FDA (U.S.). It does not specify the country of origin for the animal study or other testing data, nor whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This device is a surgical mesh, not an AI or diagnostic device that relies on expert interpretation of results for "ground truth" establishment in a diagnostic accuracy study. The "ground truth" here is established through objective physical and biological tests (e.g., tensile strength for biomechanical performance, histological assessment in animal studies for tissue response).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not a study requiring adjudication of expert opinions for a diagnostic outcome.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is not a diagnostic device or an AI-assisted interpretation tool. It is a surgical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the performance evaluation of the OrthADAPT® PR Bioimplant is based on:
- Biocompatibility Standards: Meeting established biological safety standards for medical devices.
- Biomechanical Measurements: Objective quantitative measurements of mechanical properties (e.g., tensile strength, tear resistance) against performance requirements deemed suitable for its intended use and comparable to predicate devices.
- In Vivo Animal Study Observations: Histological and functional assessments of tissue response, integration, and functionality in an animal model, conforming to expectations for surgical mesh.
- Sterility and Endotoxin Testing: Objective laboratory tests (USP sterility testing, LAL endotoxin limit).
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/machine learning device.
Ask a specific question about this device
Page 1 of 1